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ArQule's Drug Gets Orphan Drug Status for Proteus Syndrome

ArQule, Inc . ARQL announced that the first patient for the phase I trial on oncology candidate, ARQ 092, for Proteus syndrome has been enrolled.

The trial is being conducted by the National Human Genome Research Institute (NHGRI) of the National Institutes of Health. The main aim of the trial is to identify a safe and effective dose to treat Proteus syndrome in patients soon after diagnosis.

The trial is being conducted by the NHGRI in a biodynamic, dose-finding study, for which ArQule will provide ARQ 092 for the trial.

In addition, the FDA granted orphan drug designation to ARQ 092 for Proteus syndrome. The FDA usually grants orphan drug status to drugs or biologics that are being developed for the treatment of rare diseases/conditions affecting fewer than 200,000 people in the U.S. at any given time. This designation allows the product to enjoy a period of marketing exclusivity in the U.S. upon approval.

ARQ 092 is an orally available, selective pan-AKT inhibitor. We remind investors that a phase Ib clinical trial on ARQ 092 is currently ongoing in patients with lymphoma, endometrial and other cancers harboring the AKT 1 mutation.

The company regained worldwide rights for the development and commercialization of ARQ 092 and all other compounds included under its AKT collaboration with Daiichi Sankyo in 2013. ARQ 092 is the lead compound in the company's AKT program.

Meanwhile, ArQule's lead product candidate is tivantinib (ARQ 197), is being developed for liver cancer in collaboration with Daiichi Sankyo.

ArQule currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Corcept Therapeutics CORT , Biodel Inc. BIOD , and Catalyst Pharmaceuticals CPRX . While Corcept carries a Zacks Rank #1 (Strong Buy), the other two are Rank #2 (Buy) stocks.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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